Background

In recent years, with rapid development of industrial technology, the number of chemical substances manufactured of used for research purposes in various countries has been increased gradually. It is reported that currently there are millions of chemical substances available to be used, among which 70,000~80,000 are of commercial values. Admittedly, chemical substances bring extensive benefits to human society on the one hand and pose great harm to human beings and the environment with its hazardous properties on the other hand. To protect human health and envi2014 and in early 2015ronmental safety, after the implementation of EU REACH in 2007, various countries have gradually taken the initiative to formulate, release and promote new regulatory regimes to manage the manufacturing, storage and transportation activities of both new and existing substances. In China, the Measures on the Environmental Management of New Chemical Substance (MEP Order NO. 7) came into force on October 15, 2010, requiring that companies manufacturing or importing chemicals which are not listed in the Inventory of Existing Chemical Substance in China (IECSC) shall submit notification dossiers for approval and cannot commence relevant commercial activities without the notification certificate. In South Korea, the Act on Registration and Evaluation of Chemicals (a.k.a. K-REACH) came into force on January 1, 2015, requiring that existing chemical substances manufactured or imported at or over 1 ton per year as well as all new chemical substances regardless of tonnage must register before entering into the South Korean market. In Taiwan, the Toxic Chemical Substances Control Act (TCSCA) and Occupational Safety and Health Act (OSHA) are the two legislations that regulate chemical substances manufactured or imported there, the supporting regulations of which have been issued and implemented successively by the end of 2014 and in early 2015.

Differences in the requirements and scope of chemical regulations in different countries pose great challenges to manufacturers, importers and exporters in Taiwan. It is against this backdrop that REACH24H Consulting Group and Importers and Exporters Association of Taipei organize this seminar to help enterprises grasp the key points in their efforts for compliance and propose feasible coping strategies so as to avoid risks and facilitate smooth trade, with an in-depth analysis of EU REACH, China Hazardous Chemical Registration, China New Chemical Substance Notification, China GHS, K-REACH, Japan CSCL, Taiwan TCSCA and OSHA, etc.

Main Content

I. Introduction to the Measures on the Environmental Management of New Chemical Substance in China

For this topic, an overview of the regulation is to be provided, including such contents as ways to determine a new substance, scope of regulation, different types of notification, and obligations of related companies as well as special requirements of this regulation when compared to that in other countries or regions. Besides, an in-depth illustration of compliance strategies under this regulation will be provided in a case-study manner. Apart from that, an introduction to the official revision of the Guidance for New Chemical Substance Notification in 2015 will also be touched upon.

II. Interpretation of Hazardous Chemical Registration in China

In recent years, the safety management of China’s hazardous chemical substances has been drawing increasing attention from all parties. The hazardous chemical registration system of the State Administration of Work Safety is an important way adopted by the government to supervise the manufacturing, import and export of hazardous chemicals. However, a certain degree of technical difficulties do exist, making the registration no easy work and posing much pressure on many companies. This topic will start with an overview of the regulatory system of China’s hazardous chemical management and proceeds with an in-depth interpretation of key points and coping strategies in China’s hazardous chemical registration.

III. Comparative Analysis of GHS Requirements in Taiwan and Mainland China

The fact that the Globally Harmonized System of Classification and Labeling of Chemical (GHS) is actually diversified when practiced in different countries and regions troubles many companies in their import and export activities of chemicals. The GHS in different countries look similar while are actually different. Though the differences of GHS in various countries look messy, there are actually certain rules that can be followed. For this topic, a detailed comparison of GHS in terms of classification, SDS and labeling will be provided and some important points of GHS compliance calling for attention in Taiwan and Mainland China will be elaborated.

IV. Opportunities and Challenges of EU REACH under New Circumstances

Since the implementation of EU REACH, many companies have been enjoying the grace period for substances manufactured or imported at a low tonnage band. However, the last deadline of May 31, 2018 for REACH registration is coming close, with less than three years left. Companies with a low tonnage band need to attach due attention to the registration requirement. REACH is the regulation of EU on Registration, Evaluation, Authorization and Restriction of Chemicals, aimed to ensure a high level of protection of human health and the environment from the risks that can be posed by chemicals. The European Chemicals Agency (ECHA) is responsible for the review and assessment of REACH responsibilities. With the previous two deadlines of REACH registration well passed, competent authorities will naturally step up inspection before the upcoming final deadline of 2018. This topic will elaborate on the core content of EU REACH, such as the target of implementation, registration process and other relevant REACH obligations. Meanwhile, some hotspot issues concerning EU REACH under new circumstances will also be touched upon, such as the identification of substances difficult to be identified, data sharing, joint submission and information transfer, etc. REACH24H is committed to helping companies turn challenges into opportunities in their efforts for REACH compliance in order to facilitate smooth trade and secure a competitive place in the EU market.

V. Updates on the Latest Progress of K-REACH and Interpretation of Compliance Strategies

One year has passed since the implementation of K-REACH on January 1, 2015, which has posed great challenges to global chemical companies doing businesses there due to its mandatory requirements and intricate crossovers with other regulations. After implementation, the Ministry of Environment (MoE) has gradually updated some provisions of K-REACH to make the regulation easier to implement. This topic will focus on contents that companies are most concerned about such as the registration and exemption of new chemicals, joint registration of existing substances and important updates on the regulation to help companies outside South Korea formulate feasible coping strategies for compliance and facilitate smooth trade.

VI. Introduction to Regulation on Taiwan New and Existing Chemical Substances Registration & Case Studies

This topic will mainly focus on the regulatory background, new and existing chemical substance technical guidance interpretation (applicable scope, registration types, data requirements, special chemical substance or chemicals with specific use, laboratory qualification requirements, registration procedure, CBI application, listed in TCSI, information disclosure platform) , and case studies.

VII. Animal Toxicity Tests Assessment and Good Laboratory Practice in Taiwan

With the implementation of Taiwan’s New and Existing Chemical Substances Data Registration, substances falling into the Phase I registration category need to conduct at least five tests including acute toxicity, skin and eye irritation, sensitization and genotoxicity etc. Since requirements for toxicity tests are becoming increasingly strict, the GLP system is important to ensure data quality. A good management system of GLP and tests quality can effectively reduce costs caused by repeated tests. Therefore, how to select good laboratories to ensure product safety and business interest continues to be an important subject.

VIII. Introduction to Japan CSCL and Compliance Strategies for Non-Japanese Companies

Since the newly amendment of Japan Chemical Substances Control Law (Japan CSCL) came into force in 2011, the complexities of the regulation pose major regulatory and trade barriers for non-Japanese companies. This seminar will clarify the basic regulatory framework and major compliance points of Japan CSCL, and share compliance strategies with suppliers in Taiwan.

Agenda

Nov 26 A.M.

Nov 26 P.M.

Target Audience

-Decision-makers from multi-national enterprise

-Procurement managers

-Responsible persons in EHS department

-Project managers of chemical enterprise

-Responsible persons of Regulatory affairs

-Product stewardship managers

-Supply chain managers

-BD/Marketing managers

Speakers

Mr. Atlans Dai

Chemical Regulatory Compliance Expert

REACH24H Consulting Group

Master in Chemistry, Mr. Atlans Dai is a recognized expert in “China REACH” (a.k.a MEP Order No.7) and Japan CSCL. He has gained extensive hands-on experience in data gap analysis, project management, exposure scenario development etc.

Mr. William Zhou

Chemical Regulatory Compliance Expert

REACH24H Consulting Group

Master in Agricultural Pharmacology from Zhejiang University, Mr. William Zhou is a recognized expert in EU REACH and K-REACH regulatory issues. He is the core member of the team who successfully submit the first non-Korean K-REACH dossiers to Korea’s MoE in Feb 2015. He has gained extensive hands-on experience in data gap analysis, project management, exposure scenario development etc.

Mr. Leo Li

Chemical Regulatory Compliance Expert

REACH24H Consulting Group

Master in Food Engineering from Zhejiang University, Mr. Leo Li is a recognized expert in China GHS and hazardous chemicals issues. He has conducted in-depth studies on the implementation of GHS in China, the United States, Canada and many Asian countries.

Mr. Ray Huang

Chemical Regulatory Compliance Consultant

REACH24H Consulting Group

Mr. Ray Huang is graduated from Taiwan National Chiao Tung University on Applied Chemistry and Technical Management. He is an expert in Taiwan New and Existing Chemical Substance Registration under Taiwan TCSCA and OSHA with solid chemical background and years of experience in the chemical industry.

Yijie Liao Medgaea

Assistant Manager

Life Sciences Ltd.

Mr. Yijie Liao graduated from North Carolina State University of U.S. with a Master’s Degree in Business Management and from Fu Jen Catholic University of Taiwan with a Master’s Degree in Biology. He is also member of the Taiwan Society of Quality Assurance, lecturer and reviewer of Good Laboratory Practice and lecturer of TAF OECD-GLP, enjoying rich experience in preclinical safety tests and quality assurance systems.

Registration Fee

Fee: 500 TWD/seat（Taxes, Lunch, Tea Break Included）

Method of Payment: How to register? Click here to register online!

Contact Us

If you have any questions please contact: Ms. Sarah Ye Tel: +86-57- 87007555 E: chemicals@reach24h.com REACH24H Consulting Group

Organizer

REACH24H Consulting Group

REACH24H Consulting Group provides global chemical compliance solutions to assist chemical manufacturers, importers and downstream users to effectively manage their responsibilities. Our objective is to facilitate the most efficient and cost-effective access to the marketplace for our clients’ products through utilizing our strong commercial experience and technical expertise in chemical and other industries like food, agrochem, cosmetics, etc. For more detailed information, please see www.reach24h.com

Co-Organizer

Importers and Exporters Association of Taipei

Importers and Exporters Association of Taipei, established in 1947, represents businesses engaged in import-export trade. The 5,500-member strong organization is the largest importers and exporters association as well as one of the most influential private chambers of commerce in Taiwan. In light of the changing global economy and the signing of Economic Cooperation Framework Agreement (ECFA), the IEAT steps up its efforts to strengthen collaboration with trade agencies, conduct research on global trade environment and major markets, and bolster assistance to companies participating in international exhibitions, procurement and sales promotion. For more detailed information, please see http://tpchem.tworg.net/